Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion

Product NDC: 80070-360
11-digit product format: 800700360
Labeler code: 80070
Product ID: 80070-360_4b826770-8056-2806-e063-6294a90a6f11
Type: HUMAN OTC DRUG
Nonproprietary name: BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and DIPHENHYDRAMINE HYRDOCHLORIDE
Dosage form: KIT
Labeler: Foundation Consumer Brands
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-09-15
Marketing end: 2026-12-31
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	Internal RxNorm lookup
1236048	Internal RxNorm lookup
1666116	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
42720fa0-fcdd-4614-80b2-16d0ada345b1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80070-310-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	1 in 1 CARTON	ELIXIR		1 mg in 5mL	5
80070-310-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	118 mL in 1 BOTTLE	ELIXIR	236 mL	1 mg in 5mL	5
80070-340-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	118 mL in 1 BOTTLE	SOLUTION	118 mL	6.25 mg in 5mL	5
80070-340-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	1 in 1 CARTON	SOLUTION		2.5 mg in 5mL	5
80070-360-12	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	1 in 1 CARTON	KIT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-360	DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE) KIT [FOUNDATION CONSUMER BRANDS]	4	Current NDC, Legacy NDC, 5 package rows	20240119_42720fa0-fcdd-4614-80b2-16d0ada345b1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 75 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus Relief Cough Cherry Liquid	DEXTROMETHORPHAN HBR, GUAIFENSIN	Topco Associates	3170748e-b09f-4c07-9927-df43771166c5	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier application number: M012
Pain and Sinus	ACETAMINOPHEN AND PHENYLEPHRINE	JHK Inc dba American Safety & First Aid	88f86f5a-cc2b-4c75-b7a4-f2021922280b	2025-12-16	Warnings	Exact identifier application number: M012
Severe Congestion and Cough, Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	b75af815-9bd4-4a7a-bc68-f42f4af50699	2025-12-16	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fe5fd29e-7f81-4633-8c3b-010d68abe701	2025-12-16	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	e0a62fa1-9f8a-4770-b28b-1f4f02a762e0	2025-12-16	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	8c4b59b8-dfab-4f4a-9966-f07b026a758a	2025-12-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	df866cf6-0526-4e61-ac9b-245b57dd5df6	2025-12-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	c89200b6-4adb-452e-b931-07f631dad641	2025-12-16	Warnings	Exact identifier application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	45fa9159-d74c-063a-e063-6294a90a3ed0	2025-12-15	Warnings	Exact identifier application number: M012
SudoGest Nasal Decongestant	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	5229f4b2-a194-46f8-a0bc-4510fbe52075	2025-12-15	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	HEB	39178eb7-ada9-30bf-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
SF Menthol Cough Drop	MENTHOL	HEB	3a443179-b7a6-3242-e054-00144ff8d46c	2025-12-13	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	HEB	39bd0ca1-348f-0ce1-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	HEB	766236e2-3302-2232-e053-2991aa0af503	2025-12-13	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drop	MENTHOL	HEB	3a30a427-6ab4-24ae-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat and Cough Lozenges	BENZOCAINE	HEB	3063ea93-6bc2-1d18-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
HEB Menthol Cough Drops	MENTHOL	HEB	c197855d-15b4-38fc-e053-2a95a90a2dc7	2025-12-13	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666116	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) Pack	PSN	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) Pack	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1666116	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80070-310-04	80070031004	1 in 1 CARTON						Historical
80070-340-04	80070034004	118 mL in 1 BOTTLE	118 ml					Historical
80070-360-12	80070036012	1 KIT in 1 CARTON (80070-360-12) * 1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (80070-340-04) / 118 mL in 1 BOTTLE	1 kit	2021-09-15	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dimetapp ® Cold and Cough and Dimetapp ® Nighttime Cold and Congestion	Foundation Consumer Brands	2026-02-23	HUMAN OTC DRUG LABEL	5